Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

Forms and Documents

Document Name	Status
Form 3757 Initial Burden (annualized over 3 years); Initial Registration Form and Instruction	Modified
0782 83-C for form FDA 3757 6-24-2016.doc Justification for No Material/Nonsubstantive Change	2016-06-24
SS for Vending Machine Labeling Final Rule.pdf Supporting Statement A	2015-02-18

IC Document Collections

IC ID	Document Title	Status
214837	Third Party Disclosures	Unchanged
214836	Registration Renewal	Unchanged
214834	Initial Burden (annualized over 3 years); Initial Registration Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0782	ICR Reference No: 201606-0910-008
Status: Historical Active	Previous ICR Reference No: 201502-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/28/2016
	Date Received in OIRA: 06/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2018	03/31/2018	03/31/2018
Responses	7,371,355	0	7,371,355
Time Burden (Hours)	1,507,789	0	1,507,789
Cost Burden (Dollars)	0	0	0

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Abstract: This collection request seeks information from respondents to help make calorie information for vending machine foods available to prospective purchasers in a direct, accessible, and consistent manner. Under the Affordable Care Act, vending machine operators who own or operate 20 or more vending machines, or who voluntarily elect to be covered, must provide calorie declarations for those vending machine foods for which the Nutrition Facts label cannot be examined prior to purchase or for which visible nutrition information is not otherwise provided at the point of purchase.

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Authorizing Statute(s): PL: Pub.L. 111 - 148 4205 Name of Law: Affordable Care Act
   US Code: 21 USC 343 Name of Law: Nutrition Labeling and Education Act, as amended
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG56	Final or interim final rulemaking	79 FR 71259	12/01/2014

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 19238	04/06/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 71259	12/01/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Registration Renewal
Initial Burden (annualized over 3 years); Initial Registration	3757	DHHS/FDA Menu and Vending Machine Labeling Voluntary Registration
Third Party Disclosures

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	7,371,355	7,371,355	0	0	0	0
Annual Time Burden (Hours)	1,507,789	1,507,789	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $200,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Yes

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/27/2016

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